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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K252277
Device Name Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
Applicant
Vascular Flow Technologies Limited
Prospect Business Centre
Gemini Crescent
Dundee,  GB DD2 1TY
Applicant Contact Angela Paterson
Correspondent
Vascular Flow Technologies Limited
Prospect Business Centre
Gemini Crescent
Dundee,  GB DD2 1TY
Correspondent Contact Angela Paterson
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/22/2025
Decision Date 10/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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